Depression and Anxiety Trial, By Invitation
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- A person must have been diagnosed with Somatic Symptom Disorder (a condition where physical symptoms cause significant distress and are linked to excessive thoughts or feelings) according to standard psychiatric guidelines, confirmed through an interview with a qualified psychiatrist.
- A person must be receiving ongoing, regular medical care throughout the duration of the trial.
- A person must not have had any changes made to their psychiatric or heart-related medications for at least one week before the trial begins.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People younger than 18 or older than 65 years of age.
- People who experience psychotic symptoms, such as those associated with schizophrenia.
- People with significant memory or thinking difficulties, such as a diagnosis of dementia or intellectual disability, or who would have trouble completing study questionnaires.
- People who have previously had a surgical procedure to cut the vagus nerve in the neck (cervical vagotomy).
- People with serious heart or circulation conditions, including a resting heart rate that is too fast (above 100 beats per minute) or too slow (below 60 beats per minute); blood pressure that is significantly too high or too low; severe narrowing of the heart's arteries; narrowing or fatty buildup in the neck arteries; aneurysm; heart failure; serious irregular heart rhythms (such as certain electrical conduction problems, atrial fibrillation, or recent dangerous heart rhythms); or a heart attack within the last five years.
- People with serious neurological conditions, including severe head trauma, a history of epilepsy, a brain tumour, or bleeding in the brain.
- People currently diagnosed with cancer.
- People who have any active implanted medical devices (such as a cochlear implant, pacemaker, or implanted vagus nerve stimulator) or certain non-active implants that may interact with the nervous system (such as metal stents, bone plates, or screws).
- People with structural abnormalities in the neck area.
- People who are currently pregnant.
- People who wear jewellery near the ear (specifically near the tragus) that cannot be removed before using the study device.
- People with severe skin conditions at the areas where the device would be applied.
- People with a known allergy to conductive gel materials.
- People with any other significant medical condition that the trial investigator considers could affect the safety or effectiveness of the treatment being studied.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Change in Somatic Symptom Severity as Measured by the Patient Health Questionnaire-15 (PHQ-15); Change in Health Anxiety as Measured by the Health Anxiety Questionnaire (HAQ)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.